Mr.John E. Lincoln

Verification and validation requirements have always been part of the US FDA’s cGMPs. However, with increasing technology, both industry, and regulatory agencies' expectations have increased. Recent high-profile field problems indicate that V&V activities are ...

This webinar will define what are the US FDA's expectations for proper laboratory / clinical / manufacturing practices, systems, equipment usage, and documentation / record-keeping. It will evaluate the requirements for how  basic Quality Management System (QM ...

The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. However, the FDA is looking beyond th ...

This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...

This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA' s two Guidances, "510(k) Device Modifications:  Deciding When to Submit a 510( ...

The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry. Artificial ...

This webinar will discuss the US  FDA’s Final Guidance on the Q-Submission Program, dated May 29, 2025, which addresses how to request interactions with the FDA related to future medical device submissions. This allows companies and the FDA to arrive at mutual ...

This webinar will examine the existing requiements for the US  FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...

This webinar is focused on the workings of the Quality Management System, what is required of a compliant system according to ISO 9001, and the QMS audit. This seminar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ...

Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Pro ...